Remote Temperature Monitoring of Patients At Risk for Developing Fever
NCT ID: NCT06752512
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-08-09
2025-01-31
Brief Summary
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* does remote temperature monitoring reduce the number of days spent inpatient
* what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring
* the number of billable CPT codes that will be generated by providing remote temperature monitoring
Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.
Patients will
* wear the thermometer for the duration of their participation in the study
* have their temperature monitored continuously
* receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician
* respond to texts or calls from remote monitors when an alert is triggered
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Remote Patient Monitoring
Patients assigned remote patient monitoring
Remote Patient Monitoring
24/7 remote patient monitoring with a wearable thermometer
Interventions
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Remote Patient Monitoring
24/7 remote patient monitoring with a wearable thermometer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is ≥ 18 years or older.
* Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
* Subject is willing to install the TempShield app on his/her phone.
* Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
* Subject is willing to take an oral temperature as directed by their care plan.
* Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
* Subject or subject caretaker is able and willing to complete subject surveys.
* Subject is willing and able to provide written informed consent in English.
* Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.
* English speakers
Exclusion Criteria
* Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
* Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
* Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
* Subjects receiving prophylactics that could induce fever.
* Subjects with a silicon allergy
* Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.
* Subjects who are not willing to take an oral temperature per their care plan.
18 Years
ALL
No
Sponsors
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Ellis Medicine
OTHER
AION Biosystems
INDUSTRY
Responsible Party
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Principal Investigators
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Tallat Mahmood, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ellis Hospital
Locations
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Ellis Hospital
Schenectady, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Elise Currier
Role: primary
Other Identifiers
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ELLIS001
Identifier Type: -
Identifier Source: org_study_id